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NCT Number: NCT06804148

MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry

Rational of the Myval THV - Prospective German Multicenter Registry is to evaluate the performance of this relatively new but very promising TAVR valve in a consecutive real-word, all-comers registry and to assess the long-term durability and efficacy of the Myval THV.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is going to be treated with Myval THV
  • Age ≥ 18 years
  • Ability to give informed consent

Exclusion criteria

  • Pregnant and lactating women
  • Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
  • Patients in whom anti-platelet and/or anticoagulant therapy are contra-indicated.
  • Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the registry

Treatment and study plan

Myval Transcatheter Heart Valve

Device

The Myval TAVR bioprothesis is a balloon-expandable THV developed by Meril Lifesciences, which has novel operator friendly design features to improve deliverability and aid precise deployment.

Primary outcomes

  1. It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation

    Time frame: 5 Year

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Prof. Dr. med. Ingo Eitel

Other

Registry information

Acronym: German MYVAL S

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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